Final Research Plan

Screening for Speech and Language Delay and Disorders in Children Age 5 Years or Younger

The final Research Plan is used to guide a systematic review of the evidence by researchers at an Evidence-based Practice Center. The resulting Evidence Report forms the basis of the USPSTF Recommendation Statement on this topic.
The draft Research Plan was available for comment from July 25 until August 21, 2013 at 5:00 p.m., ET. To view the draft Research Plan, click here.

I. Analytic Framework

a Excluding children with diagnosed disorders including autism, mental retardation, Fragile X, hearing loss, degenerative and other neurologic conditions.b School performance, behavioral competence, socioemotional development, quality of life, and others.

II. Key Questions to Be Systematically Reviewed

Does screening for speech and language delay or disorders lead to improved speech and language outcomes, as well as improved outcomes in domains other than speech and language?

Do screening evaluations in the primary care setting accurately identify children for diagnostic evaluations and interventions?

What is the accuracy of these screening techniques and does it vary by age, cultural/linguistic background, whether it is conducted in a child's native language, or by how the screening was administered (i.e., parent report, parent interview, direct assessment of child by professional)?

What are the optimal ages and frequency for screening?

Is selective screening based on risk factors more effective than unselected, general population screening?

Does the accuracy of selective screening vary based on risk factors? Is the accuracy of screening different for children with an inherent language disorder compared with children whose language delay is due to environmental factors?

What are the adverse effects of screening for speech and language delay or disorders?

Does surveillance (active monitoring) by primary care clinicians play a role in accurately identifying children for diagnostic evaluations and interventions?

Do interventions for speech and language delay or disorders improve speech and language outcomes?

Do interventions for speech and language delay or disorders improve other outcomes, such as academic achievement, behavioral competence, and socioemotional development or health outcomes, such as quality of life?

What are the adverse effects of interventions for speech and language delay or disorders (e.g., time, stress, and stigma)?

III. Contextual Questions

Contextual questions will not be systematically reviewed and are not shown in the Analytic Framework.

What are the techniques for screening for speech and language delay or disorders and do they differ by age and cultural background?

What risk factors are associated with speech and language delay?

What is the role of primary care providers in screening in children age 5 years or younger that is performed in other venues (such as Head Start or preschool)?

IV. Research Approach

The Research Approach identifies the study characteristics and criteria that the Evidence-based Practice Center will use to search for publications and to determine whether identified studies should be included or excluded from the Evidence Report. Criteria are overarching as well as specific to each of the key questions (KQs).

Category

Include

Exclude

Populations

Children age 5 years or younger (for screening) who speak any language

Children with previously known conditions associated with language delay (e.g., hearing impairment, developmental or neurological/neurogenetic impairment)

Setting

Studies conducted in countries listed as “high” on the Human Development Index

Studies conducted in countries not listed as “high” on the Human Development Index

Screening

All instruments and procedures that are applicable for use in children age 5 years or younger:

≤10 minutes to administer or to be interpreted in a primary care setting

>10 minutes if completed by a parent or teacher and interpreted by the clinician

Instruments specifically for speech and language

General developmental instruments with a separate component for speech and/or language skills

Instruments not designed for use in children age 5 years or younger

Tools that take >10 minutes to administer

General developmental screening instruments that do not have a separate component for speech and/or language skills

Treatment/management interventions

All standardized and nonstandardized procedures to diagnose specific speech and/or language impairments that are appropriate for use in children younger than age 6 years

All therapeutic interventions designed to improve speech or language in children, as long as diagnosis occurs when child is age 6 years or younger

Therapists may be speech-language pathologists or other clinicians, parents, or teachers

Therapeutic settings include group and individual sessions offered in a clinical locale, school, or home

Diagnostic procedures administered to children older than age 6 years

Therapeutic interventions delivered to children who are diagnosed after age 6 years

IV. Response to Public Comment

The draft Research Plan was posted for public comment on the U.S. Preventive Services Task Force (USPSTF) Web site from July 25 to August 21, 2013. In response to comments, several key questions were expanded to include more detail; the USPSTF added several child and test characteristics that may affect screening, as well as several specific possible adverse effects of interventions. The USPSTF revised the analytic framework to reflect that referral and diagnostic evaluations for a speech and language delay or disorder could lead to the identification of nonspeech and language diagnostic concerns. This outcome acknowledges that speech and language screening and evaluation can be the gateway to the diagnosis of other conditions, such as autism spectrum disorder. As the framework shows, the review will not examine outcomes related to the diagnosis of other conditions. The USPSTF also added a loop in the analytic framework, from no disorder or delay detected during the diagnostic evaluation back to surveillance, to indicate that screening/surveillance can be a recurrent process.

In a recent CDC Expert Commentary on Medscape, CDC’s Director of the Immunization Safety OfficeDr. Frank DeStefano takes a detailed look at the very latest data on rotavirus vaccine and the risk of intussusception, the most common cause of acute bowel obstruction in infants. Dr. DeStefano explains that providers should be ready to talk with parents about the benefits of rotavirus vaccine, as well as the small risk for intussusception associated with the vaccines. He reminds clinicians that parents need to know the signs and symptoms of intussusception. They also need to know that they should seek prompt care if they are concerned that their child may be ill. To learn more about rotavirus, rotavirus vaccines, and the benefits and risks associated with vaccines, watch Dr. DeStefano’s commentary. For additional information, visit these websites:

Last week I had the opportunity to discuss the federal response to viral hepatitis with some of our key allies in the states: the CDC-funded Adult Viral Hepatitis Prevention Coordinators who had assembled in Washington, DC for the third National Hepatitis Technical Assistance meeting organized and hosted by the National Alliance of State and Territorial...

NIH-Supported Scientists Advocate Trying Similar Strategy in People

WHAT:Two teams are reporting results from experiments in which they infused powerful anti-HIV antibodies into monkeys infected with an HIV-like virus, rapidly reducing the amount of virus, or viral load, to undetectable levels, where it remained for extended periods. One study was led by government scientists at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and the other was led by NIAID grantees at Beth Israel Deaconess Medical Center. Both teams worked with monkeys infected with simian human immunodeficiency virus, or SHIV, which can cause AIDS in monkeys. The researchers selected monoclonal antibodies that targeted two different sites on SHIV and gave the monkeys either one or two infusions of one or a combination of two or three of these antibodies. Then the scientists measured changes in the monkeys’ viral load and their immune responses to the virus.

In the study led by NIAID grantees, the antibody infusions reduced SHIV viral load to an undetectable level in 16 of 18 monkeys within just 7 days and kept it there for a median of 56 days, when the infused antibodies were gone. While the two monkeys with the highest viral loads at the outset of the study never achieved undetectable viral loads, the three monkeys with the lowest viral loads at the outset maintained stable, undetectable viral loads long after the infused antibodies were gone. The antibody infusions appeared both to improve the monkeys’ control of the virus and to reduce the presence of SHIV DNA in blood and tissues without generating SHIV resistance to the antibodies.

In the study led by NIAID scientists, infusion of a single antibody to 4 monkeys infected for 3 months quickly reduced SHIV viral load to undetectable levels for 4 to 7 days, but then virus reappeared and strains in two animals were antibody-resistant. Yet when two asymptomatic monkeys SHIV-infected for more than 3 years received an infusion of two antibodies, viral load fell to undetectable levels within 7 to 10 days and remained there for 18 to 36 days. A second infusion reduced viral load to undetectable levels for 4 to 28 days. When virus reappeared, strains in one monkey were antibody-resistant. Infusion of the same antibody pair into three monkeys SHIV-infected for more than 3 years and with AIDS symptoms provided modest or no benefit but did not generate resistance.

The studies’ authors now propose testing antibody-based immunotherapy in HIV-infected people and exploring the potential role of antibody infusions in curing people of HIV.

CONTACT:To schedule interviews, please contact Laura S. Leifman, (301) 402-1663, laura.sivitz@nih.gov.NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at www.niaid.nih.gov. About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

NCHS Data Briefs

Having trouble viewing this email? View it as a Web page.NCHS Data Briefs from the National Center for Health Statistics, Centers for Disease Control and Prevention. The following reports have been added:

Data Brief No. 133. Hypertension Among Adults in the United States: National Health and Nutrition Examination Survey, 2011–2012Hypertension is an important risk factor for cardiovascular disease and affects almost one-third of the U.S. adult population. In 2009–2010, nearly 82% of adults with hypertension were aware of their status, and nearly 76% were taking medication. Despite considerable improvement in increasing the awareness, treatment, and control of hypertension, undiagnosed and uncontrolled hypertension among minority groups remains a challenge. This report presents survey results for 2011–2012 on the prevalence, awareness, treatment, and control of hypertension.